Unit 14 Quality Assurance in the Transfusion Service Terry Kotrla, MS, MT(ASCP)BB

History of Regulation in Blood Bank In the years before the HIV epidemic, blood banks were perceived as organizations that provided a community service Increased occurrence of HIV and increased public scrutiny resulted in stricter FDA regulations FDA regulatory oversight has resulted in an increased effort to provide a safe, high-quality product at low cost

Overview Primary goal is transfusion of a safe unit of blood. To achieve quality must have: Well constructed SOPs. Well trained personnel who carefully adhere to SOPs. Comprehensive guidelines in compliance with Joint Commission, FDA, AABB and CAP. Failure in the quality of blood collected, screening of collected blood or failure to follow procedures in transfusion protocols may result in fatal consequences.

Terms Quality control is the management of the testing process itself. Monitoring of equipment and instruments Determining that reagents are reacting appropriately. Quality Assurance includes the entire process of providing patient care, from the time the physician orders the test until treatment of patient based on results of test. Were appropriate lab tests ordered to determine the need for transfusion. Did the transfusion service perform appropriate testing of patient specimen and preparation of the appropriate component Was the transfusion administered properly. Did the patient obtain the anticipated benefit. Utilization review is the process of monitoring the appropriateness of transfusion. Continuous quality improvement involves reviewing the process of providing patient care with the goal of reducing rework, waste and inappropriate care.

Good Manufacturing Practices (cGMPs) cGMPs are legal requirements established by the FDA These regulations specify what needs to be done without specifying how it needs to be done The cGMPs are only a part of the overall quality assurance (QA) program

Quality Assurance Program (QA) QA comprises the combined activities performed by an organization Ensures the quality of products and services offered Must include cGMPs Activities must be planned and documented by written policies and procedures.

Records If it is not recorded it NEVER happened. Most common violation. Thorough record keeping essential. Recreates EVERY step related to production and distribution of blood components including individuals involved. Creates an audit trail necessary to investigate errors. Original data CANNOT be obliterated, single line. Date and initial of changes required. NO white out or pencil is ever allowed. Document control essential as it specifies and describes: media to be used, types of documents to keep and length of time.

Audit Trail A thorough record-keeping system recreates every step related to: Production Distribution of a unit of blood This step is known as an audit trail An audit trail is important when investigating errors and accidents Ability to trace back to the original entry and make corrections is also necessary in computer systems.

Document Control Regulatory and accrediting agencies expect documentation to be: Thorough Well organized Appropriately stored Retrievable in a reasonable amount of time Protected from unauthorized access Modification procedure in place Destruction procedure in place

Standard Operating Procedures (SOP) All record systems, including their control, handling, and disposal, must be thoroughly described in the SOPs Describe how a particular task is to be accomplished Are important training tools for new employees Are written using a standard format

Change Control The blood industry is in a constant state of change Challenged routinely by new technologies and regulatory and accrediting requirements Time consuming and requires money However, benefits outweigh costs Ensures that nothing “falls through the cracks

Personnel Qualifications Good employees are essential to the success of any organization Hiring unqualified individuals can add significant cost to the organization Selection process must be thorough, and minimal pre- established criteria must be identified Job descriptions list the tasks for each individual and are essential Once job is defined can then determine level of education and training required.

Training A critical aspect of compliance with cGMPs Must define tasks performed and levels of competence needed. Must have a written training program and assessment to document and determine competency of the employee. Review of SOPs Trainer's demonstration of tasks or procedure Employee’s performance with trainer’s assistance Employee’s performance without assistance

Competency Assessment When documented evidence exists that the employee is able to demonstrate knowledge and application of a new skill Initial competency assessment is done during training Periodic competency is used to determine that the employee has maintained the skill

Proof of Competency Requirements The following agencies have established requirements for proof of competency for personnel testing, twice the first year of employment and annually thereafter: The Center for Medicare and Medicaid Services AABB CLIA Corrective actions needed for unacceptability

Proficiency Testing A required component of QA program Used to ensure that test methods and equipment are working correctly Ensures that staff members are following procedures Assigning external proficiency testing samples on a rotating basis. Proficiency testing may be internal, external or both. Observing employee performing assigned tasks. Reviewing documentation. Internal - Unknown samples prepared in house External - CAP survey is one example Written exams. Corrective action is implemented and monitored for improvement when results are not acceptable

Supplier Qualifications The quality of any given product is as good as the quality of the raw materials Supplier qualification has become standard practice in blood banks Written agreements between blood banks and suppliers are common practice Specific terms of product expectations Course of action when criteria are not met

Error Management Part of a QA plan must include mechanisms for the detection and management of errors and their consequences Errors, incidents, variances, and any nonconformance should be documented and investigated Employees must involved in all aspects Root-cause analysis should be initiated

Recalls FDA requires that licensed and registered facilities report any incidences of an error or accident If the investigation reveals that the root cause was due to an error in manufacturing, a recall may take place Recalls are usually issued by manufacturers in an attempt to remove products from the market

Validation A process that establishes documented evidence providing a high degree of assurance that a specific product meets its pre- established quality and performance specifications Validation necessitates the commitment of time, resources, and manpower Must be planned and thoroughly documented

Facilities and Equipment Facilities and equipment should be designed in compliance and support of cGMPs Documentation must be made of routine maintenance, repairs and testing performed on instruments from date of receipt to date instrument is permanently removed from service. Temperature monitoring is critical for refrigerators, freezers, incubators and waterbaths. Must be manually recorded daily. Refrigerators and freezers must have a device to record the temperature 24 hours a day. When temperature is out of range must have documentation of reason or corrective action taken. Alarms on refrigerators and freezers must be tested periodically to make sure they will sound at the appropriate temperature.

Quality Assessment of Supplies and Reagents The following reagents must be tested each day of use: antihuman globulin serum blood grouping anti-serums lectins antibody screening cells reverse grouping cells Enzymes For donor collection facilities the following must be tested with each run: hepatitis testing reagents HIV testing reagents HTLV-I/II reagents ALT testing reagents syphilis serology reagents.

Quality Assessment of Supplies and Reagents When reagents and supplies are received each of the following must be documented during the log in process: date of receipt manufacturer lot number expiration date review of manufacturer's circular for changes leaking or damaged containers

Quality Assessment of Supplies and Reagents Before being placed in use reagents are tested for sensitivity and specificity. Daily testing is required to ensure the reagent has not lost potency or reactivity. Can use a formand procedure created in-house or utilize QC kit provided by a manufacturer. Lot numbers and expiration date of all reagents tested must be on the form. Graded reactions recorded. Special typing sera need only be QCd when used. Final disposition of damaged or unsatisfactory reagents must be documented.

Other Issues Lot release and label control to avoid product recall resulting from mislabeling QA department to coordinate all activities related to QA Regulatory agencies include AABB and FDA; their compliance standards should be known International Standards Organization 9000 provides guidance in the development of standards; not specific for any product or industry

Quality Assessment and Utilization Review Most facilities use the 10 step process outlined by Joint Commission Assign responsibility Delineate the scope of care Identify the most important aspect of care Identify indicators Establish thresholds Collect and organize data Evaluate data Take corrective action Assess actions and document improvement Communicate.

Transfusion Committee Medical staff responsible for assessing adequacy of transfusion services and proper use of blood components. Reviews usage of all components for appropriateness. Reviews records of all transfusion reactions. Reviews order practices.

Utilization Review Required by Joint Commission Used to assess the blood ordering and transfusion practices of the medical staff. Crossmatch:transfusion ratio Number of units crossmatched divided by the actual number transfused. Used as an indicator that too much blood is being requested to be on hold. Could result in high outdate or waste. Number of autologous transfusions.

Utilization Review Number of emergency releases. Calculate statistics by physician. Review of records to determine if transfusion was justified. Audit criteria for transfusion must be defined: Hematocrit less than 24% Hemoglobin of less than 8 gm/dL Symptoms due to anemia Recent estimated blood loss of greater than 10% of total blood volume. If audit reveals unjustified transfusion physician is notified and asked to respond.

Reference: Basic & Applied Concepts of Immunohematology, 2nd edition, Blaney. Guide to the preparation, use and quality assurance of blood components, 7th edition, Council of Europe Publishing Technical Manual American Association of Blood Banks, 11th edition Quality Assurance in Blood Transfusion Service http://www.bloodindex.net/quality_asssurance_intro.php